A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
NCT ID: NCT07156578
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
25 participants
INTERVENTIONAL
2025-11-10
2028-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bivamelagon (open-label)
Bivamelagon
daily dose of oral bivamelagon
Interventions
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Bivamelagon
daily dose of oral bivamelagon
Eligibility Criteria
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Inclusion Criteria
* Agree to use a highly effective form of contraception and follow contraception requirements throughout the study and for 90 days after.
Exclusion Criteria
* In the opinion of the Investigator, participant is not suitable to participate in the study.
12 Years
ALL
No
Sponsors
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Rhythm Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Meeker, MD
Role: STUDY_CHAIR
Rhythm Pharmaceuticals, Inc.
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
University of Iowa Children's Hospital
Iowa City, Iowa, United States
Tufts Medical Center
Boston, Massachusetts, United States
Columbia University
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, , United Kingdom
University of Cambridge
Cambridge, , United Kingdom
Great Ormond Street Hospital for Children
London, , United Kingdom
Countries
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Other Identifiers
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RM-MC72-002
Identifier Type: -
Identifier Source: org_study_id